endarterectomy versus stenting in patients with symptomatic severe carotid stenosis

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Journal Club Journal Club Ani Ani Balmanoukian and Balmanoukian and Peter Peter Benjamin Benjamin November 9, November 9, 2006 2006

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Journal Club Ani Balmanoukian and Peter Benjamin November 9, 2006. Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis. Mas et al. NEJM 355;16 October 19, 2006. Background. - PowerPoint PPT Presentation

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Page 1: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Journal Journal ClubClub

Ani Balmanoukian Ani Balmanoukian andand

Peter Benjamin Peter Benjamin

November 9, 2006 November 9, 2006

Page 2: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Endarterectomy Endarterectomy versus Stenting in versus Stenting in

Patients with Patients with Symptomatic Severe Symptomatic Severe

Carotid StenosisCarotid StenosisMas et al. Mas et al.

NEJM 355;16 October 19, NEJM 355;16 October 19, 20062006

Page 3: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

BackgroundBackground Carotid Endarterectomy is the Carotid Endarterectomy is the

standard treatment for symptomatic standard treatment for symptomatic or asymptomatic high-grade(> 60% or asymptomatic high-grade(> 60% or 70%) internal carotid artery or 70%) internal carotid artery stenosis.stenosis.

Carotid artery stenting has become Carotid artery stenting has become another optionanother option

Page 4: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Carotid EndarterectomyCarotid Endarterectomy

NASCET and ECST NASCET and ECST trials have trials have demonstrated the demonstrated the efficacy in efficacy in symptomatic symptomatic patientspatients

Complications Complications include local nerve include local nerve injury and strokeinjury and stroke

www.vascular.co.nz

Page 5: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Carotid StentingCarotid Stenting

Less invasive than Less invasive than CEACEA

Can be done under Can be done under local anesthesia and local anesthesia and sedationsedation

Less costly than CEALess costly than CEA Risk of stroke and Risk of stroke and

local complicationslocal complications Long term efficacy Long term efficacy

not well known yetnot well known yethttp://radinfo.musc.edu/~stringes/carotidimage25.jpg

Page 6: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Hypothesis/Goal: Hypothesis/Goal: Evaluate whether Evaluate whether stenting is not inferior to stenting is not inferior to endarterectomy with regard to the endarterectomy with regard to the risks of the procedure and long-term risks of the procedure and long-term efficacy in patients with symptomatic efficacy in patients with symptomatic carotid stenosis.carotid stenosis.

Design: Design: Randomized, noninferiority Randomized, noninferiority trial.trial.

Setting: Setting: 20 academic and 10 non-20 academic and 10 non-academic centers in France. academic centers in France.

Page 7: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Investigators: Investigators: Each center had to have a Each center had to have a team of physicians consisting ofteam of physicians consisting of

1 Neurologist1 Neurologist

1 Vascular surgeon: had to have 1 Vascular surgeon: had to have performed at leastperformed at least

25 CEAs25 CEAs

1 Interventional physician: had to have 1 Interventional physician: had to have performed performed

at least 12 carotid stenting at least 12 carotid stenting procedures or at procedures or at

least 35 stenting procedures in the least 35 stenting procedures in the supraaortic trunks, of which 5 supraaortic trunks, of which 5

were in the were in the carotid artery.carotid artery.

Page 8: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Participants:Participants: 527 patients >18 y/o, with 527 patients >18 y/o, with history of a history of a hemispheric or retinal TIA or a hemispheric or retinal TIA or a nondisabling stroke nondisabling stroke within 120 days within 120 days before enrollment.before enrollment.

Stenosis of 60-99% in the symptomatic Stenosis of 60-99% in the symptomatic carotid artery.carotid artery.

Exclusion: disabling stroke, Exclusion: disabling stroke, nonatherosclerotic carotid disease, previous nonatherosclerotic carotid disease, previous revascularization, bleeding disorder, revascularization, bleeding disorder, uncontrolled HTN or diabetes, unstable uncontrolled HTN or diabetes, unstable angina, life expectancy <2 years.angina, life expectancy <2 years.

Page 9: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Figure 1.Mas et al, Endarterectomy vs. stenting in patients with symptomatic severe carotic stenosis. NEJM 2006;355:1660-71

Page 10: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Data Collection: Data Collection: Evaluation by Neurologist at Evaluation by Neurologist at 48 hrs, 30 days, 6 months after treatment and 6 48 hrs, 30 days, 6 months after treatment and 6 months thereafter. months thereafter.

Outcome: Outcome: Primary: Any stroke or death occurring Primary: Any stroke or death occurring

within 30 days after treatment. within 30 days after treatment.

Secondary: MI, TIA, cranial nerve injury, Secondary: MI, TIA, cranial nerve injury, major local complications, and systemic major local complications, and systemic complications within 30 days.complications within 30 days.

Analysis: Analysis: Kaplan-Meier method, intention to Kaplan-Meier method, intention to treat principle. treat principle.

Page 11: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Table 1. Baseline Characteristics of the Patients.

Key Points• Patients overall very similar• Only differences:

• More patients older than 75 yo in CEA group (40.5% vs. 32.2%)• More patients with h/o stroke in CEA group (20.1% vs 12.6%)• Higher proportion of contralateral carotid occlusion in stenting group (none of these had a stroke after stenting)

Page 12: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Table 3: Risk of stroke or death and other outcomes within 30 days

Key Points:• Unadjusted RR of stroke/death is 2.5 for stenting vs CEA (Number Needed to Harm: 17)

• No significant correlation between RR of stroke/death and number of patients treated at each center

• No significant difference in stroke/death outcomes between interventionalists who were experienced, tutored during training, tutored after training

• Decreased incidence in stroke/death in pts who had cerebral protection along with stenting vs stenting alone

• RR stroke/death adjusted for age was 2.4, h/o stroke 2.6

• Cranial nerve injury much more likely with CEA (7.7% vs 1.1%)

Page 13: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis
Page 14: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

Conclusions/ImplicationsConclusions/Implications

In pts with symptomatic carotid stenosis In pts with symptomatic carotid stenosis >60%, CEA has lower rates of >60%, CEA has lower rates of stroke/death through 6 monthsstroke/death through 6 months

These results agree with some (e.g. These results agree with some (e.g. SPACE), but not all (e.g. SAPPHIRE) SPACE), but not all (e.g. SAPPHIRE) prior studiesprior studies

Taken together, pending further Taken together, pending further evidence, stenting should be limited to evidence, stenting should be limited to symptomatic pts with >70% stenosis symptomatic pts with >70% stenosis who are high surgical riskwho are high surgical risk

Page 15: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

StrengthsStrengths

Large, Multicenter RCTLarge, Multicenter RCT All patients accounted for at All patients accounted for at

conclusionconclusion Groups were similar at start of trialGroups were similar at start of trial

Page 16: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

WeaknessesWeaknesses

Required minimal experience for Required minimal experience for interventionalists doing procedureinterventionalists doing procedure

Didn’t indicate differences in Didn’t indicate differences in complications based on experiencecomplications based on experience

Anesthesiology or periop differences?Anesthesiology or periop differences? No standardization of stenting device No standardization of stenting device

used (5 different stents, 7 different used (5 different stents, 7 different cerebral protection systems used)cerebral protection systems used)

Page 17: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

DiscussionDiscussion What are unique aspects of a noninferiority trialWhat are unique aspects of a noninferiority trial What is the significance of an intention to treat What is the significance of an intention to treat

analysisanalysis Intricacies in a surgical rct that are uniqueIntricacies in a surgical rct that are unique

How to minimize differences in How to minimize differences in surgeon/interventionalist experience?surgeon/interventionalist experience?

How to minimize effects of other aspects (e.g. How to minimize effects of other aspects (e.g. anesthesia, postop care, etc)anesthesia, postop care, etc)

Can you standardize experience level differences Can you standardize experience level differences between CEA and carotid stenting?between CEA and carotid stenting?

Any way to blind such a trial?Any way to blind such a trial?

Page 18: Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis

ReferencesReferences

Mas JL et al. Endarterectomy versus Mas JL et al. Endarterectomy versus stenting in patients with symptomatic severe stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006 Oct carotid stenosis. N Engl J Med. 2006 Oct 19;355(16):1660-71. 19;355(16):1660-71.

North American Symptomatic Carotid North American Symptomatic Carotid Endarterectomy Trial Collaborators. Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade in symptomatic patients with high-grade carotid stenosis. N Engl J Med 1991; carotid stenosis. N Engl J Med 1991; 325:445-53.325:445-53.